JP4338976B2 - Apparatus and method for supplying ablative laser energy and determining the volume of a destroyed tumor mass - Google Patents

Description

  In situ or on-site percutaneous treatment (treatment) of malignant breast tumors with laser therapy leads to early breast cancer due to an increased number of women receiving mammograms (mammography) every year It has been developed as one of the reasons for being detected. If breast cancer and other cancers or tumors are detected at an early stage of development, the tumor can be effectively treated using an ablative agent such as laser energy.

  Image-guided laser treatment of malignant tumors such as breast, liver, head and neck tumors has been developed over the last decade. For example, US Pat. No. 5,169,396 (“the '396 patent”), patented to Dowlatshahi et al., Is directed to the interstitial application of laser radiation therapy to tumor masses. Which is incorporated herein by reference. In general, the device of the '396 patent comprises a probe with a thin metal cannula that is inserted into a tumor mass, a laser that generates light having a selected wavelength and intensity, and an optical fiber that receives the laser light and transmits it to the tumor mass. Wherein an optical fiber is inserted into the cannula so that a selected physiologically acceptable fluid can flow coaxially between the cannula and the optical fiber. Also, in order to monitor the temperature of the tumor, a heat sensing member is inserted adjacent to the tumor mass. The deprived tumor is gradually removed by the body's immune system and becomes a scar within 6 months.

  However, tumor therapy, particularly the special treatment of breast cancer, is generally difficult because it is difficult to determine the three-dimensional boundaries of the tumor and thus determine when the entire tumor has been destroyed.

  To address this problem, medical researchers have utilized various tumor mass specific methods to determine the size and outer boundary of the tumor mass. Examples of conventional specific methods used in combination with laser therapy include magnetic resonance imaging, techniques using radiation, and techniques using ultrasound. When a specific method is used, coordinates that specify the actual size of the tumor mass are determined using a stereotaxic method or the like.

  To solve this problem, during laser treatment, a marker may be placed in the 0.5-1.0 cm zone of “normal” tissue to determine the boundary of the zone where the tumor spread exists. This ring of “normal” tissue corresponds to the cuff of the tissue enclosing the tumor that is removed during conventional surgery (ie, lampectomy or tumor removal). The boundary of the ring surrounding the tumor is marked at 3 o'clock, 6 o'clock, 9 o'clock and 12 o'clock by inserting a metal marker through the needle. The insertion point is accurately determined by a known localization method using a commercially available stereotactic table.

  Such marker elements are the subject of US Pat. No. 5,853,366 (“the '366 patent”), patented to Daurazahi, and directed to marker elements for interstitial treatment. . In general, the '366 patent discloses a marker element that can be placed entirely within a patient's body by utilizing a guide member having a guide path to mark a tumor mass of interest. is there. The marker element consists of a radiation transmissive material including a material that can be detected by conventional radiation, ultrasound, or magnetism techniques.

  Medical researchers have also used non-surgical methods other than laser therapy to treat breast tumors. For example, radio frequency, microwave, and low temperature related therapies have been attempted.

  The present invention recognizes that it provides a non-resecting treatment for cancer, particularly breast cancer, that can be relied upon to determine when the above-described problems have been effectively destroyed, the entire tumor. Therefore, there is a need for a non-resectable breast cancer treatment that addresses this problem and the problems arising from the difficulty of determining whether the tumor has been completely destroyed.

  The present invention provides a graphical representation of a destroyed mass in a tissue mass (such as a breast tumor) (such as a breast cancer) in a patient's body that is preferably able to be superimposed on the image of the actual tumor mass. It solves the above-mentioned problem of providing a device and a method for determining the volume (volume) of destruction of a tumor mass and capable of visually monitoring the destruction of the tumor mass in real time. Preferred embodiments of the invention relate to breast tumors or breast cancer, although it will be appreciated that the invention applies to the treatment of other tumors or cancers. The preferred embodiment of the present invention applies to a patient placed on a commercially available stereotactic table. The present invention may also be implemented using ultrasound and magnetic resonance imaging (MRI) methods if a mass of tissue, such as a breast, is immobilized and the target is fixed.

  The apparatus of one embodiment of the present invention preferably includes a laser gun. The laser gun is configured to receive a laser probe having a temperature sensor and a temperature probe having a temperature detector group. Laser guns facilitate the insertion of a laser probe into a tumor mass to provide an effective amount of laser radiation and to measure the temperature of the tumor at the point of laser irradiation. The gun then inserts a temperature probe into the body, preferably near the tumor mass. Temperature probes measure body or tissue temperature at various locations near the tumor mass during interstitial (sex) laser treatment. The laser and temperature probes preferably include position marks so that the operator can accurately place and determine the relative position between the probes.

  The apparatus preferably includes a computer control system electrically connected to the laser gun and its components, i.e., laser probe, sensor, temperature probe and detector. The computer control system determines the volume of the destroyed tumor mass by using operational data such as the distance between the temperature sensors. The computer control system calculates the volume of the tumor mass destroyed at a given time during interstitial laser treatment based on the temperature of the tumor mass and the temperature of the body or tumor mass surrounding the tumor.

  Since the computer control system calculates the volume of the destroyed tumor mass, it displays a continuous graphical display of the destroyed tumor mass superimposed on the actual tumor mass image in real time. Therefore, this graphical display allows the physician to determine the amount of tumor mass destroyed in real time during interstitial laser treatment so that the user can determine when to effectively complete the destruction of the tumor mass. Can be monitored visually.

  Accordingly, an advantage of the present invention is to provide an apparatus and method for calculating the volume of tumor mass destruction so that a graphical representation of the destroyed tumor mass can be displayed.

  Another advantage of the present invention is that it provides for real-time visual monitoring of tumor mass destruction during laser treatment.

  Another advantage of the present invention is to provide an apparatus and method for determining when tumor mass destruction is effectively completed.

  Another advantage of the present invention is to provide an apparatus and method for determining when breast tumor mass destruction is effectively completed during interstitial laser treatment.

  Other objects, features and advantages of the present invention will become apparent from the following detailed disclosure made with reference to the accompanying drawings. Like reference numerals in the drawings denote like parts, components, methods, and steps.

  Additional features and advantages of the present invention will become apparent from the following detailed description and drawings.

  Drawings in particular, FIGS. 1A, 1B, 2A and 2B show an apparatus and method for determining the volume of a destroyed tumor mass. The present invention, as described in detail below, determines the volume of the destroyed tumor mass by determining the volume of the destroyed tumor mass based on the relative temperature of the tumor mass and the temperature of the tissue surrounding the tumor mass. The volume is displayed or displayed graphically. This display provides the physician or operator with visual monitoring of the destruction of the tumor mass in real time to determine when the destruction of the entire tumor mass has been effectively completed.

  The present invention monitors the temperature in and near the tumor mass by using a laser probe temperature sensor and an independent temperature probe with a number of temperature sensors or detectors. Temperature sensors and temperature probes provide temperature data to determine the volume of the destroyed tumor mass and to provide a real-time graphical display of the destroyed tumor mass.

  In order to calculate the destroyed tumor mass volume, the temperature probe must be accurately positioned with respect to the temperature sensor and the relative distance between them must be accurately determined. The present invention uses a number of position marks located on the temperature probe for positioning and determination of the relative position between the temperature detector and the laser probe as described below.

  In one embodiment, the present invention preferably includes a laser gun 10 that includes a probe holder 12 that is used during interstitial laser therapy. The probe holder 12 is configured to receive the laser probe 14 and the temperature probe 16. The laser probe 14 and the temperature probe 16 are removably inserted into the probe holder and extend from the probe holder. The laser probe 14 and the temperature probe 16 are fixed at positions relatively fixed by a gun. The positioning of laser probe 14 and temperature probe 16 may be manually or computer controlled in accordance with the present invention.

  The laser probe 14 includes a temperature sensor 15 and is configured to receive an optical fiber connected to a laser source 20 that is connected to a computer control system 22. The control system 22 is preferably connected to the temperature probe 16 and the temperature sensor 15 of the laser probe 14 via the temperature control device 24 to facilitate electrical connection to the computer control system 22. However, the laser probe 14 and the temperature probe 16 can each have an independent control system connected to a central computer control system (not shown).

  More particularly, the laser probe 14 includes a thin metal cannula for insertion into the tumor mass and an optical fiber for receiving and delivering laser light or radiation to the tumor mass, where the optical fiber is selected. A physiologically acceptable fluid or anesthetic is inserted into the cannula so that it can flow between the cannula and the optical fiber as described in the '396 patent. The '396 patent is incorporated herein as a reference as described above. In a preferred embodiment, the thin metal cannula is approximately 18 cm in length and is in the range of 16 gauge to 18 gauge, preferably 16 gauge stainless steel. The light or laser fiber is a quartz laser with a spherical probe having a diameter of 400 nm to 600 nm. The optical fiber can be purchased, for example, from SURGIMED, Woodland, Texas.

  A suitable fluid pump 26 can be used to supply fluid so that the center temperature of the tumor does not exceed 1000 ° C. or drop below 60 ° C. during laser treatment. In one embodiment, the fluid can be supplied at a flow rate in the range of 0.5 milliliters per minute (ml / min) to 2.0 ml / min.

  The laser source 20 generates an effective amount of laser radiation and supplies it to the laser probe 14. The laser source 20 is preferably a diode laser. In particular, the laser source 20 is, for example, a semiconductor 805 nm diode laser available from Diomed, Cambridge, UK. However, the present invention is not limited to the use of diode lasers, and a variety of different suitable laser sources can be used.

  The laser probe 14 includes the temperature sensor 15 as described above. The temperature sensor 15 is used to effectively measure the temperature of the center of the tumor mass when the tumor mass is destroyed. The temperature sensor 15 is soldered to the laser probe 14 or other attachment mechanism to measure the j tumor mass temperature at the distal end 28 of the laser probe 14, preferably located in the central region of the tumor mass. Is preferably attached directly.

  The distal end 30 of the temperature probe 16 is inserted in the body, in the vicinity of the tumor mass (ie, preferably 1.0 cm apart) and in the body tissue mass surrounding the tumor mass. The temperature probe 16 includes a group of temperature detectors or sensors 32 positioned at various distances or intervals (ie, preferably 0.5 cm) along the temperature probe. In the preferred embodiment, the temperature probe 16 is comprised of 16 gauge stainless steel, preferably in the range of 16 gauge to 20 gauge. As shown in FIG. 3, the temperature detector 32 of the temperature probe 16 is arranged at T1, T2, T3, T4 and T5. Based on this arrangement, tissue mass temperature measurements are made at various distances away from the surface of the tumor mass. This temperature data is used in relation to the relative distance of the temperature sensor to calculate the volume of the tumor mass to be destroyed, i.e. determining when the entire tumor mass is effectively destroyed as described below. Used to do.

  As mentioned above, the relative positioning of the temperature probe 16 with respect to the laser probe 14 must be determined in order to accurately calculate the volume of the tumor mass to be destroyed. As shown in FIG. 1A, the temperature probe 16 and the laser probe 14 include a number of position marks 34 to determine the relative positions of the temperature probe 16 and the laser probe 14. The position marks 34 are spaced at a suitable distance of 0.5 cm, preferably equally spaced along part of the length of the temperature probe 16 and along part of the length of the laser probe 14. However, the present invention is not limited to this distance and includes position marks spaced at various different positions. The operator uses these position marks to accurately position the laser probe and the temperature probe relative to the laser probe.

  The present invention preferably includes a computer control system 22 electrically connected to the laser gun 10 and its components, ie, the laser probe 14 having a temperature probe and temperature sensor 15. Computer control system 22 receives data from laser probe 14 and temperature probe 16 as the tumor mass is heated and destroyed. The data is used to calculate the volume of the tumor mass destroyed at any time. This calculation is based on temperature data from the temperature probe 16 and the temperature sensor 15. The computer control system 22 uses a destroyed tumor volume calculation to graphically depict the volume of the tumor mass destroyed on the display 36 connected to the computer control system 22 (ie, the tumor mass destruction zone).

  In one embodiment, the laser gun 10 inserts the laser probe 14 and the temperature probe 16 into the breast tissue 38 to destroy a tumor mass 40 placed in the breast tissue 38 of the patient 41 lying on the examination table 42. . Prior to inserting the laser probe 14 and temperature probe 16 into the breast tissue 38, the laser gun 10 is placed on a stereotactic platform or table 44 used in a conventional manner to identify the actual placement of the tumor mass 40 in the breast tissue 38. Place. In a preferred embodiment, the stereotactic platform or table 44 can be purchased from LORAD / Trex Medical Stereoguide DSM in Danbury, Connecticut, USA. However, this specification can be performed using a specific method such as conventional X-ray imaging, sound wave, heat, magnetic imaging, or the like.

  A number of marker elements 46 are preferably inserted into the tumor tissue 38 proximate to the breast cancer 40 after the location of the tumor mass 40 has been identified. The marker element 46 is used to treat (treat) the tumor mass 40 and subsequently identify the area to be treated as described in '366, which is incorporated herein by reference as described above. And used to enable observation.

  By knowing the actual location of the tumor mass, the laser gun 10 is configured so that the laser probe 14 and the temperature probe 16 are inserted into the breast tissue at an optimal relative position with respect to the tumor mass 40 in the breast tissue 38. Can do. The present invention utilizes a probe guide 48 so that the temperature probe 16 and the laser probe 14 can be easily inserted into the breast tissue 38. The positioning of the laser probe 14, temperature probe 16, and marker element 46 relative to the positioning of the tumor mass 40 and the tissue mass around the tumor mass can be visually monitored on the display 36.

  As described above, the present invention utilizes the laser gun 10 to insert the laser probe 14 and the temperature probe 16 into the tumor mass and the tissue mass around the tumor mass. The laser gun 10 may be made of any suitable material and may be made of a variety of different configurations. An example of such an arrangement is the configuration illustrated in FIG. 1B.

  The laser gun 10 is disposed on a guide mechanism 52 of a localization table 44 that can position the laser gun 10 before inserting the laser probe and the temperature probe. The laser gun 10 includes a housing 54 for a laser probe, a temperature probe, and a probe holder 12 that can extend from the housing for each of the laser probe and the temperature probe. The laser gun 10 further includes an alignment member 56 attached to the housing for aligning the laser gun prior to insertion. The laser gun 10 can include an insertion member 58 attached to the housing for further automatic insertion of the laser probe and temperature probe. The laser gun 10 is connected to a control system 59 that includes a computer processing unit 60. The control system 58 operates to control and monitor the temperature probe and the laser probe during laser therapy, for example, to control the laser source and fluid pump and monitor the temperature.

  First, the laser probe 14 is optimally inserted into the center of the tumor mass as shown in FIG. 2B. Once the laser probe 14 is optimally inserted into the tumor mass 40, the temperature probe 16 is also optimally inserted and positioned parallel to the laser probe 14 as shown in FIGS. 2A and 2B (ie, , Preferably about 1 cm away from the laser probe). Optimal placement of temperature probe 16 and laser probe 14 is necessary to monitor the concentric zone of heat emitted from the probe of the laser probe during treatment.

  Because of the importance of accurate positioning of the laser probe 14 and temperature probe 16 with respect to the tumor mass 40, the present invention preferably utilizes a localization (stereofixation) method in combination with marker elements to monitor this positioning. The present invention further utilizes a plurality of position marks 34 disposed on each of the temperature probe 16 and the laser probe 14 to monitor the axial positioning of the laser probe 14 relative to the temperature probe 16. As described above, the position marks 34 are separated by a known distance, preferably 0.5 cm, along each of the temperature probe 16 and the laser probe 14. Accordingly, the position mark 34 is utilized to visually monitor the relative positioning of the temperature probe 16 and the laser probe 14, thereby automatically adjusting the computer relative to the relative positioning of the laser probe 14 and the temperature probe 16. In addition, manual adjustment is possible.

As shown in FIG. 3, the temperature probe 16 preferably includes a temperature detector T3 that contacts the outer surface of the tumor mass 40 to measure temperature at this location. Other temperature detectors T1, T2, T4 and T5 are arranged at a distance (as described above) from T3 along the temperature probe. Each temperature detector is also located at various radial distances from the laser probe 14, i.e. the temperature sensor Tc of r1, r2, r3, r4 and r5 (i.e. the temperature at the center of the tumor mass). The radial distance between Tc and T3 (ie r3), ie the axial distance between Tc and T3, preferably 1.0 cm, is known. From Tc to T1, T2, T4 and T5 by knowing the distance between T3 and other temperature detectors (ie, T1, T2, T4 and T5) and the radial distance between T3 and Tc In the radial distance, the Pythagorean theorem is applied to a right triangle in which the hypotenuse length H and the side lengths A and B define a right angle and the relationship H ² = A ² + B ² Can be determined by

For example, when T1−T3 = 1.0 cm and r3 = 1.0 cm, (r1) ² = (T1−T3) ² + (r3) ² = (1.0 cm) ² + (1.0 cm) ² = 2.0 cm ² . Therefore, r1 = r5 = (2.0 cm ² ) ^1/2 = 1.4 cm. According to the same calculation, when T1−T2 = 0.5 cm and r3 = 1.0 cm, r4 = r2 = 1.10 cm. Thus, the temperature at the laser fiber probe, i.e. the temperature of the tissue around the tumor relative to Tc, varies with various known corresponding radial distances from the laser fiber probe, e.g., r1 = 1.4 cm, r2 = 1.10 cm, r3 = 1.0 cm, r4 = 1.10 cm, r5 = 1.4 cm, and MoN can be performed by the temperature detectors T1, T2, T3, T4 and T5.

By determining the radial distance, a volume calculation is performed at each temperature detector position, preferably based on a known calculation for the volume V of the sphere. V is V = 4 / 3πr ³ where r is the radial distance from the center of the sphere and π is a globally accepted constant of 22/7, ie any sphere Is the value of the ratio of the circumference of the sphere to the diameter of. When the temperature in any one of the temperature detectors reaches a level at which the tumor mass is destroyed, the volume calculation at each of the temperature detectors is related to the temperature detectors, ie, r1, r2, r3, r4 and r5. Effectively matches the volume of the tumor mass destroyed within a spherical region with a given radial distance.

  For example, when laser radiation is first applied, the tumor mass 40 is destroyed in Tc or an area near Tc. Over time, the volume of the destroyed tumor mass increases in relation to the increase in temperature measured at T3. Therefore, the volume of the destroyed tumor mass is effectively smaller than the volume corresponding to the spherical region having the radial distance r3.

  When T3 reaches or rises to the temperature that destroys the tumor mass, ie, the tumor mass destruction temperature, preferably 60 ° C., the volume of the destroyed tumor mass is greater than the volume corresponding to the spherical region having the radial distance r3. Valid matches. The globular shape of the destroyed tumor mass was recorded for mammalian rodent tumors and 36 patients with breast cancers that were subsequently removed by a pathologist after the laser-treated tumor and had a partially cut breast cancer Has been.

  In order to ensure that the entire tumor mass has been effectively destroyed, the temperature measured at other or outside temperature detectors, ie T1, T2, T4 and T5, is reduced to the tumor mass destruction temperature, preferably 60 ° C. Laser therapy (treatment) continues until it reaches or rises. When this occurs, the tumor mass is effectively destroyed within the volume of the spherical region having a radial distance related to the temperature associated with the outer temperature detector, ie, r1, r2, r4 and r5. The laser treatment is terminated when the temperature measured with the outermost temperature detectors such as T1 and T5 reaches or rises to the tumor mass destruction temperature, preferably 60 ° C.

It should be appreciated that the amount of laser energy required to destroy the tumor mass and the tissue mass around the tumor mass can be determined. Based on studies conducted by the inventor, destruction of a tumor mass of about 1 cm ³ and / or a tissue mass around the tumor mass requires about 2500 Joules (J) of laser energy. (For example, “Stereotactically Guided Laser Therapy of Occult Breast Tumors” by Dowlatshahi et al., ARCH. SURG., 135, 1345-1352, November 2000, See). By calculating the amount of tumor mass destroyed and assuming that the amount of tumor mass destruction is about 2500 J / cm ³ , the amount of laser energy (J) required to destroy the volume of the tumor mass can be calculated .

  It should be appreciated that the present invention is not limited in the number, type, location and arrangement of temperature detectors. Various arrangements and numbers of detectors may be used depending on, for example, the conditions of tumor therapy (treatment, measures), eg, tumor type and location. In a preferred embodiment, the temperature detector effectively monitors the destruction of the tumor mass relative to the radial distance from the actual tumor mass associated with the outer temperature detectors (ie, T1 and T5). Be placed.

  It should be appreciated that the present invention has no limitation on tumor mass destruction temperature. A variety of different temperatures may be used to correspond to the tumor mass destruction temperature depending on the tumor treatment as described above. In a preferred embodiment, a suitable tumor mass destruction temperature is at least 60 ° C.

  The computer control system uses the tumor mass destruction calculation as described above, preferably as shown in FIG. 4A, of the destroyed tumor mass superimposed on the actual tumor mass image taken prior to treatment. A graphic display 62 or display is provided. The tumor mass graphic display 62 is preferably displayed as a circle (2D) or a sphere (3D). Marker elements are also displayed graphically with the tumor mass.

  In FIG. 4B, display 62 shows laser probe 14 and temperature probe 16 after insertion into breast tissue. The probe 64 of the laser probe 14 is arranged at the center in the tumor mass 40, and the temperature probe 16 is arranged with respect to the laser probe 14 as described above. As the temperature increases as it is spatially concentrically spaced from the probe of the laser probe, the temperature detector at T3 measures the tumor mass destruction temperature (ie, preferably 60 ° C.). At this temperature, the destroyed tumor mass symbol 66 appears as shown in the display of FIG. 4B. When temperatures T1 and T5 reach the tumor mass destruction temperature, the destroyed tumor mass symbol 67 expands to include the destroyed tumor mass region associated with T1 and T5, as shown in FIG. 4C.

  The tumor mass symbol extends outward from the actual tumor mass image by a distance related to the location of the temperature probe's outer temperature detector (ie, T1 and T5). At this distance, tumor mass destruction is effectively completed as shown in FIG. 4C. This distance is in the range of about 0.25 cm to about 0.75 cm, and preferably in the range of about 0.4 cm to about 0.5 cm. The graphic display of the present invention allows visual monitoring of tumor mass destruction in real time, compared to known displays that only show the temperature at various locations of the tumor mass with conventional bar graphs. Is.

  For real-time visual monitoring of tumor mass destruction, another embodiment of a graphical display of tumor mass destruction at the beginning, after and at the end of laser treatment is shown in FIGS. 4D, 4E, 4F, 4G and Shown in 4H. FIG. 4 shows a tumor without a destruction zone. 4E, 4F, 4G, and 4H illustrate a fracture zone that increases in size to extend beyond the tumor zone. It should be appreciated that the tumor mass and destruction zone can be graphically represented using different cross-hatch, shading, and graphical displays. It should also be appreciated that different colors can be used to illustrate the tumor mass and destruction zone.

  In addition, it should be appreciated that a graphical display of temperature can be made in connection with the graphical image described above. FIGS. 4I and 4J show bar graphs that are preferably provided to the operator of the system. The bar graph shows the temperature at Tc, T1, T2, T3, T4 and T5 at different times. As shown in FIG. 4I, the temperature at Tc is much higher than the temperature at T3, the temperature at T3 is higher than the temperature at T2 and T4, and the temperature at T2 and T4 is higher than the temperature at T1 and T5. high. As the tumor mass destruction temperature increases at these points and the destruction zone increases, the bar graph changes to a point in time as shown in FIG. 4J. In this respect, the tumor mass destruction temperature is preferably over 60 ° C. in the T1 and T5 regions. Thus, the operator knows that the chunk has been destroyed in addition to the graphical display described above.

  In other embodiments, the present invention utilizes a blood circulation test in combination with real-time visual monitoring to determine when all destruction of the tumor mass is effectively completed. Any blood circulation test can be used. However, color Doppler ultrasound with enhanced contrast is a preferred technique. This technique circulates in the tumor mass and the tissue mass around the tumor mass (ie, breast tissue), so that the appropriate contrast agent and the appropriate transducer supermeter are used to observe the blood using the collar. It uses sound waves. Blood circulation tests are performed before and after treatment, and the results are compared to determine if the tumor mass is effectively destroyed.

  Any suitable transducer and contrasting may be used. In a preferred embodiment, the transducer ultrasound is 7.5 MHz linear array transducer ultrasound available from ATL, Botel, Washington.

  The contrast agent is preferably an ultrasonically decomposed albumin matrix material, that is, an albumin matrix material having gas injection bubbles. It should be appreciated that the reflection of sound waves from the bubbles in the albumin matrix material provides a color response indicative of blood flow or circulation. In particular, the contrast agent is OPTISON, which can be purchased from St. Marine Crode, Missouri, USA.

  Prior to treatment, an effective amount of contrast agent is preferably injected into the blood vessel. Contrast agents are used to enhance blood circulation images obtained from color Doppler ultrasound. The effectiveness of the contrast agent is shown by comparing the color Doppler ultrasound blood flow images of FIGS. 5A and 5B. A contrast agent was used to generate the blood flow images of FIGS. 5A and 5B. By comparing these figures, the blood flow image of FIG. 5B is enhanced more than the blood flow image of FIG. 5A.

  Returning to FIG. 5B, contrast-enhanced color Doppler ultrasound measured a substantial amount of blood flow within the tumor mass and the tissue mass surrounding the tumor mass. Following treatment, additional contrast agent is injected to observe blood flow in and around the tumor mass. As expected, there was no effective blood flow in the tumor mass and the surrounding area, as measured by the ultrasound method described above as shown in FIG. 5C. This indicates that the tumor mass and the tissue mass around the tumor mass were effectively destroyed. If the tumor mass and the tissue mass around the tumor mass are effectively destroyed, blood circulation in this treatment area cannot be observed by color Doppler ultrasound. A comparative analysis between pre-treatment and post-treatment blood circulation results is used to determine whether the entire tumor mass has been destroyed.

  This change in blood circulation within and around the tumor mass can also be observed by injecting an effective amount of contrast agent into the blood vessel during laser treatment. This allows real-time monitoring of blood circulation within the tumor mass and tissue mass around the tumor mass during laser treatment. The greater the destruction of the tumor mass and the tissue mass around the tumor mass, the less blood will circulate through this area. When the blood circulation is reduced, the blood circulation reduction as described above can be effectively measured using a blood circulation test such as color Doppler ultrasound. A graphical display of color Doppler ultrasound results can be continuously monitored during laser therapy. The graphical display can be displayed on a separate display or can be superimposed on the actual image of the tumor mass during laser treatment. The graphical display provides real-time monitoring of tumor destruction before the patient leaves the table. If a portion of the target tissue exhibits blood flow suggesting viability, further laser treatment can be performed. It should be appreciated that the graphical display can be configured in an appropriate manner so that blood flow circulation can be monitored.

  The actual tumor mass destroyed during the laser treatment of the present invention is shown in FIG. The void area indicates the area where the tumor mass and surrounding tissue mass were destroyed by laser treatment. As shown in FIG. 6, the void region is circular in shape and has a diameter of about 2.5 cm-3.0 cm. The red ring is an inflammatory zone where tissue within the area has been destroyed. The diameter of this ring corresponds to the diameter of the avascular region visualized with the color Doppler ultrasound illustrated in FIG. 5C.

  The present invention provides a method for determining the volume of a destroyed tumor mass. The method preferably includes the step of equipping a laser gun. The laser gun further includes a laser probe and a temperature probe as detailed above. The laser probe and temperature probe are inserted into the patient's body so that the laser probe is inserted into the tumor mass and the temperature probe is inserted into a tissue mass adjacent to the tumor mass. An effective amount of laser radiation is generated and directed through the laser probe toward the tumor mass. The temperature sensor of the laser probe measures the tumor mass temperature within the tumor mass. The temperature probe measures the tissue temperature of the tissue mass around the tumor mass at various locations along the temperature probe. The computer control system is preferably electrically connected to the laser gun and its components, namely the laser probe, the temperature sensor of the laser probe, the temperature probe and the fluid pump. The computer control system receives the temperature and temperature and laser data from the laser probe to determine or calculate the volume of tumor mass destruction as described above. The computer (or operator) regulates the fluid flow provided by the fluid pump so that the tumor mass center temperature Tc does not exceed 100 ° C. and not below 60 ° C. during laser treatment.

  The computer control system uses this calculation to form a display that graphically superimposes the destroyed tumor mass on the actual tumor mass image. By graphically showing the amount of tumor mass destroyed, the physician can visually monitor tumor mass destruction in real time to determine when tumor mass destruction has been effectively completed as described above. Can do.

  In other embodiments, the methods of the invention include identifying a tumor mass prior to inserting a laser gun into the tumor mass. The identifying step is performed using conventional radiation, ultrasound or magnetic imaging methods. As described above, it is preferable to determine the coordinates for specifying the actual position of the tumor mass using the localization method or the like.

  In other embodiments, the present invention uses a blood circulation test, such as color Doppler ultrasound, before and after treatment to provide further evidence when the entire tumor mass is effectively destroyed as described above. Blood circulation tests are used during laser treatment to allow real-time monitoring of tumor mass destruction as described above.

  It should be appreciated that the present invention is not limited to interstitial laser therapy, particularly interstitial laser therapy for breast cancer destruction. The present invention can be applied to a variety of different non-surgical treatments for the destruction of a variety of different tumor masses.

  It should be understood that variations and modifications can be effected without departing from the spirit of the invention and the scope of novel use. It should also be understood that this application is subject only to limitations within the scope of the present invention.

  It should also be understood that various changes and modifications to the preferred embodiment of the present invention will be apparent to those skilled in the art. Such variations and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its intended advantages. Accordingly, such modifications and changes are included in the scope of the claims of the present application.

1 is a schematic block diagram of an apparatus of the present invention for determining the volume of a tumor mass to be destroyed 1 is a perspective view of an apparatus of the present invention showing a laser gun. It is a schematic block diagram of a laser probe and a temperature probe before inserting into a tissue mass or body including a tumor mass. It is a schematic block diagram of a laser probe and a temperature probe inserted into a tissue mass or body including a tumor mass. FIG. 3 is a schematic diagram of a laser probe and a temperature probe illustrating a relationship between a volume of a destroyed tumor mass and a temperature sensor of the laser probe and a temperature detector of the temperature probe. (A) Graphically superimposed tumor mass destruction zone at the beginning of laser therapy for visual real-time monitoring of tumor mass destruction. (B) Graphically superimposed tumor mass destruction zone at a stage after the initial stage of laser treatment for visual real-time monitoring of tumor mass destruction. (C) Graphically superimposed tumor mass destruction zone at the last stage of laser treatment for visual real-time monitoring of tumor mass destruction. (D) Another graphical representation of a tumor mass destruction zone at the beginning of laser treatment for visually monitoring in real time the destruction of the tumor mass. (E) Another graphical representation of a tumor mass destruction zone at a stage after the initial stage of laser therapy for visually monitoring tumor mass destruction in real time. (F) shows another graphical representation of the tumor mass destruction zone at a stage after the initial stage of laser therapy for visually monitoring the destruction of the tumor mass in real time. (H) shows another graphical representation of the tumor mass destruction zone at the last stage of laser treatment for visual real-time monitoring of tumor mass destruction. (I) Other graphical bar displays of temperatures at Tc, T1, T2, T3, T4 and T5 at different stages of tumor mass destruction. (J) Other graphical bar displays of temperatures at Tc, T1, T2, T3, T4 and T5 at different stages of tumor mass destruction. It is a figure which shows the blood flow in the tumor lump before and after the treatment and the tissue lump surrounding the tumor lump measured by color Doppler ultrasound, and shows the blood flow before the treatment when no contrast agent is used. FIG. It is a figure which shows the blood flow in the tumor lump before and after the treatment and the tissue lump surrounding the tumor lump measured by color Doppler ultrasound, and the blood flow before the treatment when a contrast agent is used. FIG. It is a figure which shows the loss of the blood flow after a treatment. It is a photograph which shows the actual tumor mass destroyed by the laser treatment of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Laser gun 14 Laser probe 15 Temperature sensor 16 Temperature probe 22 Computer control system 34 Position mark 38 Tissue mass 40 Tumor mass 62 Display

Claims (8)

A cannula,
(I) is configured to receive the optical fiber,
(Ii) configured to allow a physiologically acceptable fluid to flow around the fiber;
(Iii) configured to measure the temperature of the tumor mass;
(Iv) a cannula including one or more position marks ;
A temperature probe,
(I) configured to measure one or more tissue temperatures in the vicinity of the tumor mass;
(Ii) a temperature probe including one or more position marks associated with the one or more position marks of the cannula to facilitate determination of the relative position of the cannula with respect to the temperature probe;
A display device;
A computer controller configured to connect to the cannula, the temperature probe, and a display device,
(I) determining the amount of tumor mass destroyed based on at least one tissue temperature in the vicinity of the tumor mass;
(Ii) A device for monitoring the destruction of a predetermined amount of tumor mass , comprising : a computer control device that graphically displays the amount of the destroyed tumor mass on the display device. The apparatus of claim 1 , wherein the temperature probe includes five spatially spaced temperature detectors. The apparatus of claim 1 , wherein the graphical display is a bar graph. The apparatus of claim 1 including means for performing blood circulation test using a contrast agent to determine the tumor mass destruction. The apparatus of claim 4, wherein the blood circulation test means includes means for performing a contrast-enhanced color Doppler ultrasound test. A laser probe,
(I) having at least one temperature sensor;
(Ii) operable to impart a predetermined amount of laser energy to the tissue mass ;
(Iii) a laser probe operable to determine the temperature of the tissue mass ;
A temperature probe,
(I) having at least one temperature sensor;
(Ii) a temperature probe operable to determine a plurality of tissue temperatures in the vicinity of the tissue mass ;
Laser energy comprising: the laser probe and a display operable with the temperature probe to provide a graphical display of the volume of tissue mass destroyed based on at least one tissue temperature in the vicinity of the tissue mass; Equipment to carry to. The apparatus of claim 6 including means for performing a blood circulation test utilizing a contrast agent to determine tumor mass destruction. 8. The apparatus of claim 7 , wherein the means for performing the blood circulation test comprises a contrast-enhanced color Doppler ultrasound test .

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